NCT00003556

Brief Summary

Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery. Vaccines may make the body build an immune response that may kill tumor cells. Combining more than one vaccine may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

August 17, 2004

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

2.3 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

Biological: ALVAC-hB7.1Biological: canarypox-hIL-12 melanoma vaccine

Interventions

ALVAC-hB7.1BIOLOGICAL
Arm I
canarypox-hIL-12 melanoma vaccineBIOLOGICAL
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma that is surgically incurable * At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection * If only one accessible lesion is available, it must be at least 2 cm * If two or more accessible lesions exist, then none of them are required to be at least 2 cm PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-2 * Life expectancy: Greater than 3 months * Leukocyte count at least 3,000/mm3 * Platelet count at least 120,000/mm3 * SGOT and alkaline phosphatase less than 5 times normal * Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis) * BUN less than 40 mg/dL * Creatinine less than 2.5 mg/dL * No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias * Not positive for hepatitis B virus * Not positive for HIV * No history of allergy to vaccinia virus * No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix * Not pregnant or nursing * Fertile patients must use effective contraception * No underlying immunodeficiency disorder PRIOR CONCURRENT THERAPY: * At least 30 days since prior biologic therapy (e.g., interferon or IL-2) * At least 30 days since prior chemotherapy * No concurrent steroids * At least 30 days since prior radiotherapy * Prior radiotherapy to no greater than 50% of nodal groups * No prior splenectomy * No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert M. Conry, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 17, 2004

Study Start

January 1, 1999

Primary Completion

May 1, 2001

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

US(1)